US6010494A - Connection system for medical applications - Google Patents

Connection system for medical applications Download PDF

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Publication number
US6010494A
US6010494A US09/048,681 US4868198A US6010494A US 6010494 A US6010494 A US 6010494A US 4868198 A US4868198 A US 4868198A US 6010494 A US6010494 A US 6010494A
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Prior art keywords
cannula
apertures
connection system
chamber
channel
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Expired - Lifetime
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US09/048,681
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Dieter Schafer
Thomas Frei
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Roche Diabetes Care Inc
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Disetronic Licensing AG
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Assigned to DISETRONIC LICENSING AG reassignment DISETRONIC LICENSING AG ASSIGNMENT OF ASSIGNORS INTEREST (SEE DOCUMENT FOR DETAILS). Assignors: FREI, THOMAS, SCHAFER, DR. DIETER
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Assigned to ROCHE DIAGNOSTICS INTERNATIONAL AG reassignment ROCHE DIAGNOSTICS INTERNATIONAL AG MERGER (SEE DOCUMENT FOR DETAILS). Assignors: DISETRONIC LICENSING AG
Assigned to ROCHE DIABETES CARE, INC. reassignment ROCHE DIABETES CARE, INC. ASSIGNMENT OF ASSIGNORS INTEREST (SEE DOCUMENT FOR DETAILS). Assignors: ROCHE DIAGNOSTICS INTERNATIONAL AG
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    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M5/00—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
    • A61M5/14—Infusion devices, e.g. infusing by gravity; Blood infusion; Accessories therefor
    • A61M5/162—Needle sets, i.e. connections by puncture between reservoir and tube ; Connections between reservoir and tube
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61J—CONTAINERS SPECIALLY ADAPTED FOR MEDICAL OR PHARMACEUTICAL PURPOSES; DEVICES OR METHODS SPECIALLY ADAPTED FOR BRINGING PHARMACEUTICAL PRODUCTS INTO PARTICULAR PHYSICAL OR ADMINISTERING FORMS; DEVICES FOR ADMINISTERING FOOD OR MEDICINES ORALLY; BABY COMFORTERS; DEVICES FOR RECEIVING SPITTLE
    • A61J1/00—Containers specially adapted for medical or pharmaceutical purposes
    • A61J1/05—Containers specially adapted for medical or pharmaceutical purposes for collecting, storing or administering blood, plasma or medical fluids ; Infusion or perfusion containers
    • A61J1/06—Ampoules or carpules
    • A61J1/065—Rigid ampoules, e.g. glass ampoules
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61J—CONTAINERS SPECIALLY ADAPTED FOR MEDICAL OR PHARMACEUTICAL PURPOSES; DEVICES OR METHODS SPECIALLY ADAPTED FOR BRINGING PHARMACEUTICAL PRODUCTS INTO PARTICULAR PHYSICAL OR ADMINISTERING FORMS; DEVICES FOR ADMINISTERING FOOD OR MEDICINES ORALLY; BABY COMFORTERS; DEVICES FOR RECEIVING SPITTLE
    • A61J1/00—Containers specially adapted for medical or pharmaceutical purposes
    • A61J1/14—Details; Accessories therefor
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M39/00—Tubes, tube connectors, tube couplings, valves, access sites or the like, specially adapted for medical use
    • A61M39/02—Access sites
    • A61M39/0247—Semi-permanent or permanent transcutaneous or percutaneous access sites to the inside of the body

Definitions

  • the present invention refers to a connection system for connecting a cannula with a rounded cannula end and a chamber containing a flexible substance and two apertures, the flexible substance connecting both apertures via a channel, wherein the rounded cannula end is made of an inorganic material.
  • Patent specification WO 89/06987 describes a connection system between a port system implantable inside the human body tissue and a catheter.
  • a port chamber is arranged in a human or animal body to which a catheter remaining inside the body and an external catheter, pushed from the outside into the port chamber, can be attached.
  • the inside of the port chamber contains a silicon membrane which can be punctured by the external catheter.
  • a cannula is attached to the external catheter to avoid damaging the membrane during puncturing, withthe cannula end puncturing the silicon membrane containing a spherical end.
  • Such a system is sold under the PERCUSEAL® trademark.
  • the disadvantage of this system is that the spherical end molded on the cannula is made of plastic.
  • the plastic surface contains brows, is extremely rough and damages the silicon membrane when the cannula is inserted into the port chamber. A damaged silicon membrane can no longer satisfactorily fulfill its function of preventing foreign bodies from entering the body.
  • connection systems between a cannula carrier for subcutaneous or intravenous steel or Teflon cannulas and a catheter are known.
  • the steel or Teflon cannula supported by a carrier attached to the skin is releasably connected to a puncturing tool which assists in pushingthe canula under the skin or into a vien.
  • the puncturing tool is removed and an infusion catheter with a cannula support is coupled in its place.
  • a pointed coupling cannula attached to the infusion catheter is used which is pushed into a respective receiving element in the cannula carrier.
  • the insertion of the pointed coupling cannula is often problematic as an incorrect insertion angle can cause the tip to penetrate the side wall instead of running inside the guided channel.
  • the infusion catheter also has to be secured to the cannula carrier with a fixing device to prevent detachment of the coupling cannula from the cannula carrier.
  • a coupling mechanism is, for instance, described in patent specification WO 94/20160.
  • connection systems between drug ampoules and an infusion catheter are also known.
  • the infusion catheter contains a female Luer at the end facing the ampoule with the ampoule containing a male Luer.
  • a connection is formed by pushing the female Luer over the male Luer.
  • the disadvantage of this system is that the connection between the male and female Luer is highly tolerance-dependent and that already slight angular deviations can cause a leak.
  • the invention aims to remedy these disadvantages.
  • the invention aims to provide a connection system for connecting a container containing a drug to a container or body receiving a drug, which can be used several times and permits certain manufacturing tolerances without adversely affecting the imperviousness of the system.
  • the invention also solves the task with a connection system for connecting a cannula with a rounded cannula end and a chamber containing a flexible substance and two apertures, the flexible substance connecting both apertures via a channel, wherein the rounded cannula end is made of an inorganic material.
  • the invention offers the principle advantages that due to the material selection and processing according to the invention the flexible membrane in a respective chamber is no longer damaged to the same extent as in a cannula with a molded plastic ball and that the flexibility of the membrane can compensate for certain manufacturing tolerances.
  • FIG. 1 represents a connection system according to the invention
  • FIG. 2 represents a connection system according to the invention including a spherical end pushed over the cannula;
  • FIG. 3 represents a connection system according to the invention with a spherical end placed on the cannula;
  • FIG. 4 represents a connection system according to the invention including a pressed cannula end
  • FIG. 5 represents a connection system according to the invention for a port system
  • FIG. 6 represents a connection system according to the invention for subcutaneous or intravenous Teflon or steel cannula
  • FIG. 7 represents a connection system according to the invention for a drug ampoule.
  • a connection system consists of a membrane chamber 1 with two opposing apertures 2, 3 of a different size, a membrane 4 arranged between the apertures 2, 3 made from a flexible material and containing in its center a connecting channel 5 between both apertures 2, 3 of the chamber 1.
  • a cannula 21 with a spherical end 22 can be pushed through the facing aperture 2 of chamber 1 and through channel 5 to the opposing aperture 3 and can be removed again in the same manner.
  • the diameter of the aperture 3 opposing the cannula 21 is smaller than the spherical end 22 of the cannula 1.
  • the membrane 4 in the chamber 1 is mechanically pressurized so that the channel 5 is self-closing and consequently prevents foreign bodies from penetrating into and through the channel 5.
  • the spherical end 22 When inserting the cannula 21, the spherical end 22 must open the channel 5.
  • the cannula is always surrounded by the membrane 4 so that when the spherical end 22 of the cannula 21 reaches the opposing aperture 3, sealing is guaranteed.
  • the chamber 1 and membrane 4 are designed in such a way that the spherical end 22 of the cannula 21 is retained in the opposing aperture 3 after its insertion.
  • the diameter of the opposite aperture 3 is smaller than the diameter of the spherical end 22 of the cannula 21, the cannula cannot be fully pushed through the chamber 1 but only up to the stop of the spherical cannula end 22 ate the internal chamber wall, level with the opposite aperture 3.
  • the membrane 4 in the area of the opposite aperture 3 is formed in such a way that the spherical end 22 is pressed against the internal chamber wall of the opposing aperture 3.
  • the spherical cannula end 22 is preferably produced from an inorganic material and provided with a finely machined surface whose roughness does not exceed 0.8 ⁇ m. As shown in FIGS. 2-4, the spherical end containing a diametrical through-bore 8 can either be pushed over the cannula 21 (FIG. 2) or connected to the cannula (FIG. 3). It is also feasible to produce the cannula from a material which itself is rounded off by the pressure on the cannula end. In this case a spherical end is unlikely, which explains the respective design of FIG. 4.
  • the preferred material for the spherical end 22 or the rounded end 22 of the cannula 21 is chrome nickel steel.
  • the preferred material for the membrane 4 is silicon.
  • the unit In case of placing or joining the spherical end 22 to the cannula 21, the unit is secured with a soldered join 7.
  • FIG. 5 shows a port system which is inserted into the body of an organism.
  • an anchoring plate 13 anchoring the membrane chamber 1 in the tissue, is directly connected to the membrane chamber 1.
  • the cannula 21 is pushed through the facing aperture 2 and then through the membrane chamber 5 up to the aperture 3 facing away from the cannula.
  • the membrane 4 surrounds the spherical cannula end 22 in such a way that the cannula 21 is forced against the aperture 3 facing away from the cannula.
  • An internal catheter 8 is directly connected to the aperture 3 facing away from the cannula so that a drug channel leading from an infusionhose 23 into the organism is created.
  • the spherical end 22 of the cannula 21 can also be arranged on an injection device so that the injection device carries out an injection directly through chamber 1 into a body located behind the chamber.
  • FIG. 6 shows a connection system according to the invention between a cannula carrier 41 for a subcutaneous Teflon cannula 42 and an infusion hose 23.
  • FIG. 7 shows a connection system according to the invention between an ampoule 51 and an infusion hose 23.
  • the chamber 1 is attached to an ampulla 51.
  • drugs can be administered into the ampoule or the ampulla can be emptied.

Abstract

The present invention provides a connection system for connecting a cannula to a device, the system involving a chamber operably coupled to the device, wherein the chamber has two apertures and contains a flexible substance, one of the apertures operably coupled to the device and both apertures operably linked by a channel defined in the flexible substance, the cannula having a cannula diameter and an end with a larger diameter than said cannula diameter.

Description

PRIORITY CLAIM
This application claims priority of Swiss patent application 1997 0730/97, filed Mar. 26, 1997, which is hereby fully incorporated herein by reference.
BACKGROUND OF THE INVENTION
1. Field of the Invention
The present invention refers to a connection system for connecting a cannula with a rounded cannula end and a chamber containing a flexible substance and two apertures, the flexible substance connecting both apertures via a channel, wherein the rounded cannula end is made of an inorganic material.
2. Description of the Related Art
Various connection systems between a catheter and a body are known in medical engineering. Patent specification WO 89/06987 describes a connection system between a port system implantable inside the human body tissue and a catheter. A port chamber is arranged in a human or animal body to which a catheter remaining inside the body and an external catheter, pushed from the outside into the port chamber, can be attached. The inside of the port chamber contains a silicon membrane which can be punctured by the external catheter. A cannula is attached to the external catheter to avoid damaging the membrane during puncturing, withthe cannula end puncturing the silicon membrane containing a spherical end. Such a system is sold under the PERCUSEAL® trademark. The disadvantage of this system is that the spherical end molded on the cannula is made of plastic. The plastic surface contains brows, is extremely rough and damages the silicon membrane when the cannula is inserted into the port chamber. A damaged silicon membrane can no longer satisfactorily fulfill its function of preventing foreign bodies from entering the body.
Furthermore, connection systems between a cannula carrier for subcutaneous or intravenous steel or Teflon cannulas and a catheter are known. In many cases the steel or Teflon cannula supported by a carrier attached to the skin is releasably connected to a puncturing tool which assists in pushingthe canula under the skin or into a vien. After correctly positioning the cannula, the puncturing tool is removed and an infusion catheter with a cannula support is coupled in its place. For the coupling, a pointed coupling cannula attached to the infusion catheter is used which is pushed into a respective receiving element in the cannula carrier. The insertion of the pointed coupling cannula is often problematic as an incorrect insertion angle can cause the tip to penetrate the side wall instead of running inside the guided channel. The infusion catheter also has to be secured to the cannula carrier with a fixing device to prevent detachment of the coupling cannula from the cannula carrier. Such a coupling mechanism is, for instance, described in patent specification WO 94/20160.
Connection systems between drug ampoules and an infusion catheter are also known. In most cases, the infusion catheter contains a female Luer at the end facing the ampoule with the ampoule containing a male Luer. A connection is formed by pushing the female Luer over the male Luer. The disadvantage of this system is that the connection between the male and female Luer is highly tolerance-dependent and that already slight angular deviations can cause a leak.
SUMMARY OF THE INVENTION
The invention aims to remedy these disadvantages. The invention aims to provide a connection system for connecting a container containing a drug to a container or body receiving a drug, which can be used several times and permits certain manufacturing tolerances without adversely affecting the imperviousness of the system.
The invention also solves the task with a connection system for connecting a cannula with a rounded cannula end and a chamber containing a flexible substance and two apertures, the flexible substance connecting both apertures via a channel, wherein the rounded cannula end is made of an inorganic material.
The invention offers the principle advantages that due to the material selection and processing according to the invention the flexible membrane in a respective chamber is no longer damaged to the same extent as in a cannula with a molded plastic ball and that the flexibility of the membrane can compensate for certain manufacturing tolerances.
BRIEF DESCRIPTION OF THE DRAWINGS
Preferred embodiments of the invention are shown in the figures, in which:
FIG. 1 represents a connection system according to the invention;
FIG. 2 represents a connection system according to the invention including a spherical end pushed over the cannula;
FIG. 3 represents a connection system according to the invention with a spherical end placed on the cannula;
FIG. 4 represents a connection system according to the invention including a pressed cannula end;
FIG. 5 represents a connection system according to the invention for a port system;
FIG. 6 represents a connection system according to the invention for subcutaneous or intravenous Teflon or steel cannula; and
FIG. 7 represents a connection system according to the invention for a drug ampoule.
DESCRIPTION OF THE PREFERRED EMBODIMENTS
As shown in FIG. 1, a connection system according to the invention consists of a membrane chamber 1 with two opposing apertures 2, 3 of a different size, a membrane 4 arranged between the apertures 2, 3 made from a flexible material and containing in its center a connecting channel 5 between both apertures 2, 3 of the chamber 1. A cannula 21 with a spherical end 22 can be pushed through the facing aperture 2 of chamber 1 and through channel 5 to the opposing aperture 3 and can be removed again in the same manner. The diameter of the aperture 3 opposing the cannula 21 is smaller than the spherical end 22 of the cannula 1.
The membrane 4 in the chamber 1 is mechanically pressurized so that the channel 5 is self-closing and consequently prevents foreign bodies from penetrating into and through the channel 5. When inserting the cannula 21, the spherical end 22 must open the channel 5. The cannula is always surrounded by the membrane 4 so that when the spherical end 22 of the cannula 21 reaches the opposing aperture 3, sealing is guaranteed.
The chamber 1 and membrane 4 are designed in such a way that the spherical end 22 of the cannula 21 is retained in the opposing aperture 3 after its insertion. As the diameter of the opposite aperture 3 is smaller than the diameter of the spherical end 22 of the cannula 21, the cannula cannot be fully pushed through the chamber 1 but only up to the stop of the spherical cannula end 22 ate the internal chamber wall, level with the opposite aperture 3. The membrane 4 in the area of the opposite aperture 3 is formed in such a way that the spherical end 22 is pressed against the internal chamber wall of the opposing aperture 3.
In order to prevent damaging the membrane 4, the spherical cannula end 22 is preferably produced from an inorganic material and provided with a finely machined surface whose roughness does not exceed 0.8 μm. As shown in FIGS. 2-4, the spherical end containing a diametrical through-bore 8 can either be pushed over the cannula 21 (FIG. 2) or connected to the cannula (FIG. 3). It is also feasible to produce the cannula from a material which itself is rounded off by the pressure on the cannula end. In this case a spherical end is unlikely, which explains the respective design of FIG. 4.
The preferred material for the spherical end 22 or the rounded end 22 of the cannula 21 is chrome nickel steel.
The preferred material for the membrane 4 is silicon.
In case of placing or joining the spherical end 22 to the cannula 21, the unit is secured with a soldered join 7.
The connection system according to the invention has various types of application. FIG. 5 shows a port system which is inserted into the body of an organism. In this port system an anchoring plate 13, anchoring the membrane chamber 1 in the tissue, is directly connected to the membrane chamber 1.
The cannula 21 is pushed through the facing aperture 2 and then through the membrane chamber 5 up to the aperture 3 facing away from the cannula. Once the spherical cannula end 22 is located at the aperture 3 facing away from the cannula, the membrane 4 surrounds the spherical cannula end 22 in such a way that the cannula 21 is forced against the aperture 3 facing away from the cannula. An internal catheter 8 is directly connected to the aperture 3 facing away from the cannula so that a drug channel leading from an infusionhose 23 into the organism is created.
Instead of a connection to an infusion hose 23, the spherical end 22 of the cannula 21 can also be arranged on an injection device so that the injection device carries out an injection directly through chamber 1 into a body located behind the chamber.
FIG. 6 shows a connection system according to the invention between a cannula carrier 41 for a subcutaneous Teflon cannula 42 and an infusion hose 23.
FIG. 7 shows a connection system according to the invention between an ampoule 51 and an infusion hose 23. The chamber 1 is attached to an ampulla 51. Via the connection system, drugs can be administered into the ampoule or the ampulla can be emptied.

Claims (16)

We claim:
1. A connection system comprising a cannula with a rounded cannula end and a chamber having two apertures and containing a flexible substance, the flexible substance connecting both apertures via a channel, characterized in that the cannula is generally cylindrical and has a diameter and said rounded cannula end is made of an inorganic material and has a diameter larger than the diameter of the cannula.
2. The connection system according to claim 1, characterised in that the rounded cannula end is spherical.
3. The connection system according to claim 2, characterised in that the roughness of the cannula end does not exceed 0.8 μm.
4. The connection system according to claim 3, characterised in that the cannula end is made of metal.
5. The connection system according to claim 4, characterised in that the channel through the flexible substance is self-closing.
6. The connection system according to claim 5, characterised in that the chamber is also a port chamber.
7. A connection system for connecting a cannula to a device, said system comprising a chamber operably coupled to the device, said chamber having two apertures and containing a flexible substance, one of said apertures operably coupled to the device and said apertures operably linked by a channel defined in the flexible substance, said cannula having a cannula diameter and an end with a larger diameter than said cannula diameter.
8. The connection system according to claim 7, wherein the channel is self-closing.
9. The connection system according to claim 8, wherein the surface roughness of the spherical end does not exceed 0.8 μm.
10. The connection system according to claim 9, wherein the chamber is a link to one of a cannula support and an ampoule.
11. The connection system according to claim 9, wherein the chamber is a portion of an ampoule.
12. A method of coupling a cannula and another device, comprising the steps of:
providing a connection member having a wall defining a chamber, said chamber having two generally opposed apertures and containing a flexible material, one of said apertures operably coupled to the device, a channel defined in the flexible material and extending between said apertures; and
providing the cannula with a generally spherical end having a larger diameter than the cannula, whereby said spherical end is receivable in the one of said apertures generally opposed to the one of said apertures operable coupled to the device and is movable through the channel to and from a position generally adjacent to the aperture operably coupled to the device.
13. A connection system for coupling an external substance delivery member and an internal catheter, said system comprising;
a connection member operably coupled to the catheter and having a wall defining a chamber, said chamber having two generally opposed apertures and containing a flexible material, one of said apertures operably coupled to the catheter, a channel defined in the flexible material and extending between said apertures; and
wherein the external substance delivery member has a length and generally rounded end having a larger diameter than the length, whereby said generally rounded end is receivable in the one of said apertures generally opposed to the one of said apertures operably coupled to the catheter and is movable through the channel to and from a position generally adjacent to the aperture operably coupled to the catheter.
14. The connection system according to claim 13, wherein the rounded end is generally spherical.
15. The connection system according to claim 14, wherein the channel is self-closing.
16. The connection system according to claim 15, wherein the surface roughness of the generally spherical end does not exceed 0.8 μm.
US09/048,681 1997-03-26 1998-03-26 Connection system for medical applications Expired - Lifetime US6010494A (en)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
CH00730/97A CH691726A5 (en) 1997-03-26 1997-03-26 A connecting system for medical applications.
SE0730/97 1997-03-26

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DK0867198T3 (en) 2003-11-24
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ATE246019T1 (en) 2003-08-15
DE59809118D1 (en) 2003-09-04
EP0867198B1 (en) 2003-07-30
EP0867198A2 (en) 1998-09-30

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